Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial (NCT07746388) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial
30 participantsStarted 2026-09-01
Plain-language summary
This research study is being done to find out if a drug called cemiplimab is safe in adult patients who have non-small cell lung cancer (NSCLC) that can be surgically removed (resectable Stage II, IIIA, or select IIIB NSCLC). The purpose of this study is also to look at how well the study drug works and whether certain patients can skip chemotherapy before their surgery. The goal is to see if they can safely avoid the harsh side effects of chemo and still have a successful outcome.
The investigators are doing this study because the investigators want to find out if this treatment approach is better or worse than the usual approach for early-stage NSCLC that can be surgically removed. The usual approach for the participants type of cancer is treatment with a combination of platinum-doublet chemotherapy and an immune checkpoint inhibitor (ICI) such as cemiplimab (LIBTAYO®) given before the tumor is surgically removed. (Immune checkpoint is a normal part of the immune system used to prevent an immune response from becoming so strong that it inadvertently destroys healthy cells in the body).
Cemiplimab is given via infusion and will be administered at the study center. Everyone on the study will get the active study drug, cemiplimab. No one will get placebo. Placebos look like the study drug but don't have medicine in them.
Infusion of cemiplimab will be given for 2 cycles followed by an evaluation. An evaluation means that participants will have imaging studies ("scans") done to see if the tumor has changed. After the scans, participants may receive one final cycle of cemiplimab followed by resection (surgery to remove the tumor) or combination chemotherapy plus cemiplimab for 2 cycles followed by resection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years or older at time of study entry
. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
. Participants with histologically confirmed stage II-IIIB(N2) NSCLC (per the 9th International Association for the Study of Lung Cancer) with disease that is considered resectable prior to initiation of systemic therapy.
. Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the appropriateness for resection.
. Participants must have a tumor tissue sample available for biomarker testing, including PD-L1 IHC testing and sequencing to confirm EGFR/ALK status. Assessment of PD-L1 IHC, EGFR/ALK status may be performed locally through a CLIA approved laboratory testing method.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether PD-L1 high NSCLC patients can skip chemotherapy and get immunotherapy alone before surgery — how do we know whether my tumor's PD-L1 level is high enough to even be considered for this kind of approach?
2Since this trial is Phase 2 and hasn't started recruiting yet, what does that mean for how much is already known about the safety and effectiveness of this chemo-free immunotherapy strategy compared to the standard chemotherapy-plus-immunotherapy approach that already has more data behind it?
3The trial's main goal is achieving a 'major pathologic response' — meaning a big reduction in tumor cells at surgery — can you explain what that means for my specific situation and whether that's the right goal to prioritize for my stage of disease?
4Because this trial is for stage II through IIIB resectable lung cancer, and surgery is still part of the plan, how would enrolling in this trial affect the timing of my operation, and what happens if my tumor doesn't respond well enough before surgery?
5Given that this trial hasn't started recruiting yet, is there a standard treatment I should be considering right now, and would starting standard care affect my eligibility if I wanted to discuss this trial later once it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants must have established PD-L1 Tumor Proportion Score (TPS) expression \> or equal to 50%, assessed locally through a CLIA approved laboratory testing method.
. All suspicious mediastinal/hilar lymph nodes including those that are pathologically enlarged or FDG avid on PET/CT require further sampling for pathological confirmation if accessible by mediastinoscopy, thoracoscopy, or EBUS.
. Absence of major associated pathologies that increase the surgery risk to an unacceptable level
Exclusion criteria
. Presence of locally advanced unresectable (regardless of stage) or metastatic disease (stage IV).
. Participants with large-cell neuroendocrine carcinoma tumor or small cell carcinoma histology, including those with presence of mixed histology.
. Participants with known sensitizing EGFR mutations (L858R, Exon 19 deletion, Exon 20 insertion, atypical mutations including G719X L861Q, S768I) or ALK translocation via local CLIA approved testing methods.
. Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging procedures.
. Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways.
. Active prior malignancy within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast.
. History of allogeneic organ transplantation.
. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.